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FDA 510(k)

IG 4 IMAGE GUIDED SYSTEM

K-Number: K093995 · 2010-01-27

ApplicantVeran Medical Technologies, Inc.
Decision Date2010-01-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IG 4 IMAGE GUIDED SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2010-01-27 under 510(k) number K093995. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IG 4 IMAGE GUIDED SYSTEM?

IG 4 IMAGE GUIDED SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-27. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K093995.

When did IG 4 IMAGE GUIDED SYSTEM receive FDA 510(k) clearance?

IG 4 IMAGE GUIDED SYSTEM received FDA 510(k) clearance on 2010-01-27, under 510(k) number K093995.

Who is the listed applicant for IG 4 IMAGE GUIDED SYSTEM?

The FDA 510(k) record lists Veran Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IG 4 IMAGE GUIDED SYSTEM?

The FDA product code for IG 4 IMAGE GUIDED SYSTEM is JAK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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